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OncoGenex Reports Financial Results for Fourth Quarter and Fiscal Year 2008 and Provides Outlook for 2009 Conference Call on Wednesday

Key Takeaway: OncoGenex Reports Financial Results for Fourth Quarter and Fiscal Year 2008 and Provides Outlook for 2009 Conference Call on Wednesday, March 11, 2009 at 4:30 p.m. Eastern Time BOTHELL, Washington and VANCOUVER, British Columbia, Canada March 11, 2009 OncoGenex Pharmaceutical

Full Press Release Details

OncoGenex Reports Financial Results for Fourth Quarter and Fiscal Year
2008 and Provides Outlook for 2009
Conference Call on Wednesday, March 11, 2009 at 4:30 p.m. Eastern Time
BOTHELL, Washington and VANCOUVER, British Columbia, Canada March 11, 2009 OncoGenex
Pharmaceuticals, Inc. ( OncoGenex or the Company ) (NASDAQ: OGXI), today announced its fourth
quarter and fiscal year 2008 financial results, reviewed the Company s highlights and provided an
2008 was a tremendously active year from an execution standpoint as we took measures to prepare
for the final stages of clinical development of our lead product candidate, OGX-011, for the
treatment of cancer and to position for long term growth of the Company, said Scott Cormack,
President and Chief Executive Officer of OncoGenex. We released Phase 2 clinical data showing a
survival benefit in patients treated with OGX-011 and are working closely with the FDA to develop
Phase 3 study designs and protocols defining a registration path for product approval. We also took
measures to extend our cash runway, and we have been advancing discussions with potential
development partners.
Key Objectives for 2009
The following consolidated results reflect the operations of OncoGenex Technologies Inc.
( OncoGenex Technologies ) prior to the August 21, 2008 reverse takeover of Sonus Pharmaceuticals,
Inc. ( Sonus ), and the consolidated results of the OncoGenex Pharmaceuticals thereafter.
Research and development expenses for the fourth quarter and year ended December 31, 2008 were $4.2
million and $7.8 million, respectively, compared to $1.1 million and $4.1 million, respectively, in
the corresponding periods of 2007. The increases in 2008 were primarily due to manufacturing costs
incurred in the fourth quarter of 2008 associated with the development of our product candidate
OGX-427, an increase in employee expenses and higher facility costs resulting from the reverse
General and administrative expenses for the fourth quarter and year ended December 31, 2008 were
$1.0 million and $3.3 million, respectively, compared to $0.8 million and $3.5 million,
respectively, in the corresponding periods of 2007. The increase for the fourth quarter of 2008 was
primarily due to increased employee expenses and increased costs associated with operating as a
public company. The decrease for the year ended December 31, 2008 was primarily due to higher
financing related costs incurred during the year ended December 31, 2007, partly offset by higher
employee expenses and increased costs associated with operating as a public company in 2008.
Net loss for the fourth quarter and year ended December 31, 2008 was $5.0 million and $6.2 million,
respectively, compared to net losses of $3 million and $11.5 million, respectively, in the
corresponding periods of 2007. The increase for the fourth quarter of 2008 was primarily due to
increased employee expenses, costs associated with the development of OGX-427 and increased costs
associated with operating as a public company. The decrease for the year ended December 31, 2008
was primarily due to the impact of an extraordinary gain recognized in connection with the reverse
takeover of Sonus and a reversal of tax expense associated with the change in capital structure of
OncoGenex Technologies, both non-cash items.
The Company had $12.4 million in cash, cash equivalents and short-term investments as of December
31, 2008, compared to $5.1 million as of December 31, 2007. The Company expects that operating
expenses for 2009 will remain consistent with 2008 and believes it has sufficient cash, cash
equivalents and short-term investments to fund ongoing operations through February 2010. The
Company had 5,548,469 shares outstanding as at March 3, 2009.
OGX-011 Development Highlights
As the data from Phase 2 studies of OGX-011 have matured over the past year, we are gaining a
clearer picture of the potential clinical utility of OGX-011, particularly regarding the benefits
of overall survival and pain palliation for the treatment of CRPC, said Cormack. The endpoints
of survival and pain palliation from our Phase 2 studies directly translate into our Phase 3
development plan. We believe such endpoints are the only critical and relevant primary endpoints for Phase 3 trials in patients with CRPC and for
ultimately achieving marketing approval.
Results from our Phase 2 clinical development program are summarized below:
patients who had received OGX-011 with first-line chemotherapy were alive. OncoGenex has
previously reported a mature median survival of 14.1 months and a one-year survival rate of
54%. For comparison, published studies using a first-line gemcitabine and platinum-based
chemotherapy for advanced NSCLC reported median survivals of 8 to 10.8 months and one-year
survival rates of 33% to 43%. Market approval for Avastin plus paclitaxel and carboplatin
chemotherapy for NSCLC was based on results showing a median survival of 12.3 months
compared to 10.3 months for patients treated with paclitaxel and carboplatin chemotherapy
alone. Survival rates for Avastin plus chemotherapy versus chemotherapy alone were reported
as 51% versus 44%, respectively, at one year and 23% versus 15%, respectively, at two
With a robust clinical and non-clinical data package supporting OGX-011, we are working closely
with the FDA to develop Phase 3 study designs and protocols defining a registration path for
product approval, added Cormack.
Other Pipeline Highlights
Corporate Highlights
Conference Call Today at 4:30 p.m. ET
OncoGenex management will host a conference call at 4:30 p.m. Eastern Time today, Wednesday, March
11, 2009, to provide a business update and discuss the fourth quarter and fiscal year 2008 results.
A live webcast and slide presentation will be available through the Events and Presentations Web
page found in the Investor Relations section of the OncoGenex Web site at www.ir.oncogenex.com.
Alternatively, you may access the live conference call by dialing 877-874-1569 (U.S. Canada) or
719-325-4767 (International). A webcast replay will be available approximately two hours after the
call and will be archived at the same Web location for 90 days.
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new
therapies that address unmet needs in the treatment of cancer. OncoGenex has a deep oncology
pipeline, with each product candidate having a distinct mechanism of action and representing a
unique opportunity for cancer drug development. OGX-011, the lead candidate currently completing
five Phase 2 clinical studies in prostate, lung and breast cancers, is designed to inhibit the
production of a specific protein associated with treatment resistance; OGX-427 is in Phase 1
clinical development; SN2310 has completed the Phase 1 clinical trial; and CSP-9222 and OGX-225 are
currently in pre-clinical development. More information about OncoGenex is available at
This press release contains forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995, including statements concerning
the Company s key objectives for 2009, potential results of clinical trials, the potential benefits
of the Company s product candidates and other anticipated activities, achievements, occurrences and
performance. These statements are based on management s current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that could cause actual results to
differ materially from those described in the forward-looking statements. All statements other than
statements of historical fact are statements that could be deemed forward-looking statements.
The potential risks and uncertainties associated with forward-looking statements include, among
others, the possibility that an agreement with the FDA cannot be reached regarding a clinical trial
using pain as the primary endpoint for OGX-011, the timing and costs of clinical trials and
regulatory approvals, risks that clinical trials will not be successful or confirm earlier or
interim clinical trial results, the Company s need for additional financing, the uncertainty
associated with any potential partnering discussions, risks relating to the development, safety and
efficacy of therapeutic drugs and potential applications for these products and the risk factors
set forth in the Company s filings with the Securities and Exchange Commission, including its
Annual Report on Form 10-K for fiscal year 2008. No assurances can be given that any of the events
anticipated by the forward-looking statements will transpire or occur, or that if any of them do
transpire or occur, what impact they would have on the results of operations or financial condition
Last updated: Mar 11, 2009